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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name radiological computer assisted detection/diagnosis software for lesions suspicious for cancer
510(k) Number K181704
Device Name Transpara
ScreenPoint Medical BV
Stationsplein 26
Nijmegen,  NL 6512AB
Applicant Contact Nico Karssemeijer
ScreenPoint Medical BV
Stationsplein 26
Nijmegen,  NL 6512AB
Correspondent Contact Nico Karssemeijer
Regulation Number892.2090
Classification Product Code
Date Received06/27/2018
Decision Date 11/21/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No